Note: This document contains side effect information about avacopan. Some dosage forms listed on this page may not apply to the brand name Tavneos.

Applies to avacopan: oral capsule.

Serious side effects of Tavneos

Along with its needed effects, avacopan (the active ingredient contained in Tavneos) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking avacopan:

More common

• Bladder pain
• bloody or cloudy urine
• chest pain or tightness
• cough
• dark urine
• difficult, burning, or painful urination
• fever or chills
• frequent urge to urinate
• loss of appetite
• lower back or side pain
• nausea or vomiting
• sneezing
• sore throat
• stomach pain, severe
• trouble breathing
• unusual tiredness or weakness
• yellow eyes or skin

Less common

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Other side effects of Tavneos

Some side effects of avacopan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• diarrhea
• dizziness
• headache
• skin rash

For Healthcare Professionals

Applies to avacopan: oral capsule.

Musculoskeletal

Common (1% to 10%): Increased creatine phosphokinase^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection^[Ref]

Hepatic

Very common (10% or more): Hepatic-related adverse reactions, including hepatobiliary adverse reactions and liver enzymes abnormalities (13.3%)

Common (1% to 10%): Transaminase elevations^[Ref]

Respiratory

Common (1% to 10%): Pneumonia^[Ref]

General

The most frequent serious adverse reactions reported have included pneumonia, acute kidney injury, and urinary tract infection.^[Ref]

Nervous system

Very common (10% or more): Headache (20.5%), fatigue (10.2%)

Common (1% to 10%): Dizziness, paresthesia^[Ref]

Renal

Common (1% to 10%): Acute kidney injury, increased serum creatinine^[Ref]

Cardiovascular

Very common (10% or more): Hypertension (18.1%)^[Ref]

Dermatologic

Very common (10% or more): Rash (11.4 %)

Common (1% to 10%): Angioedema^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (15.1%), nausea (23.5%), vomiting (15.1%)

Common (1% to 10%): Upper abdominal pain^[Ref]